FDA.reportPublic FDA data

Application 020626

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMITREXSUMATRIPTANSPRAY;NASAL5MG/SPRAYYesYes
002IMITREXSUMATRIPTANSPRAY;NASAL10MG/SPRAYNoNo
003IMITREXSUMATRIPTANSPRAY;NASAL20MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0523IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0523IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0523IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0523IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0523IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0524IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0524IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0524IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0524IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0524IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0781-6523SUMATRIPTANsumatriptanSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6523SUMATRIPTANsumatriptanSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6523SUMATRIPTANsumatriptanSandoz IncNDACurrent
0781-6523SUMATRIPTANsumatriptanSandoz IncNDACurrent
0781-6524SUMATRIPTANsumatriptanSandoz IncNDACurrent
0781-6524SUMATRIPTANsumatriptanSandoz IncNDACurrent
0781-6524SUMATRIPTANsumatriptanSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6524SUMATRIPTANsumatriptanSandoz IncNDA AUTHORIZED GENERICCurrent
66993-081SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-081SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-081SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-082SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-082SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-082SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84455SUPPL 2025-12-18
84382SUPPL 2025-12-10
50707SUPPL2017-12-15
50698SUPPL2017-12-15
25347SUPPL2013-11-27
34977SUPPL2013-11-26
12866SUPPL2012-03-06
25346SUPPL2012-03-05
2904SUPPL2012-03-05
34976SUPPL2010-07-31
34975SUPPL2010-07-31
12865SUPPL2010-07-31
25345SUPPL2010-07-28
2903SUPPL2010-07-28
2902SUPPL2010-07-28
41492ORIG2010-03-03
20772SUPPL2008-08-04
20771SUPPL2008-08-04
20773SUPPL2007-07-24
23586ORIG2007-01-17
25342SUPPL2004-10-15
12864SUPPL2004-10-15
25344SUPPL2003-08-15
25343SUPPL2002-05-10
52212SUPPL1900-01-01
52211SUPPL1900-01-01
52210SUPPL1900-01-01
52209SUPPL1900-01-01
52208SUPPL1900-01-01
52207SUPPL1900-01-01